Identity
- Trade Name
- Portex FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Model / Reference
- H1051 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10351688434678 FDA UDI
- 510(k) Number
- K952214 FDA UDI
- FDA Product Code
- NHK FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary resuscitator, manual, single-use
A comprehensive medical device directory with a detailed overview of the Portex pulmonary resuscillator, manual, single-use device.
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Cleared under the same submission
K952214 also covers:
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
- Portex — ICU MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 18f55266-b728-4ecb-9344-d4d8133f7e29 33 fields · synced Jun 29, 2026